Fluent Fluid Management System
FDA 510(k) clearance K180825 · decided 2018-08-03
Clearance details
- K-number
- K180825
- Device name
- Fluent Fluid Management System
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-03-30
- Decision date
- 2018-08-03
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- HIG
- Device class
- 2
- Regulation number
- 884.1700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Malborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
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